Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

iTOF®

K-Number: K242525 · 2024-12-05

ApplicantNerbio Medical Software Platforms, Inc.
Decision Date2024-12-05
Product CodeKOI
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

iTOF® is a medical device manufactured by Nerbio Medical Software Platforms, Inc.. It received FDA 510(k) clearance on 2024-12-05 under approval number K242525. The device is classified under product code KOI. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the iTOF®?

iTOF® is a medical device that received FDA 510(k) clearance on 2024-12-05. It is manufactured by Nerbio Medical Software Platforms, Inc.. The 510(k) number is K242525.

When was iTOF® approved by the FDA?

iTOF® received FDA 510(k) clearance on 2024-12-05, under approval number K242525.

What company makes iTOF®?

iTOF® is manufactured by Nerbio Medical Software Platforms, Inc..

What is the FDA product code for iTOF®?

The FDA product code for iTOF® is KOI.

Related Devices (Code: KOI)

K162048EZstim*III Peripheral Nerve Stimulator/Nerve LocatorHalyard Health - Irvine K172690ToFscanIdmed K172843TwitchView SystemBlink Device Corporation K190795Tetragraph Neuromuscular Transmission MonitorSenzime AB K192958TwitchView SystemBlink Device Company K213316Life Scope PT BSM-1700 Series, AY Series, Data Acquisition Unit, LIFE SCOPE BSM 6000 SERIES BEDSIDE MONITORING SYSTEM, Nihon Kohden CSM-1901 BEDSIDE MONITORING SYSTEMNihon Kohden Corporation

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

↑